Regarding a German court's finding that Celltrion's Eylea biosimilar "Eydenzelt (ingredient: aflibercept)" infringed the formulation patent of original-drug developers Regeneron and Bayer, Celltrion said it is "in active patent settlement talks with the original developers."
Eydenzelt is a biosimilar of the blockbuster ophthalmology treatment "EYLEA," co-developed by U.S. Regeneron and Germany's Bayer. The original drug EYLEA recorded global sales of $9.523 billion (13.3322 trillion won) in 2024. Of that, U.S. sales were $5.968 billion (about 8.3552 trillion won), accounting for more than half of the total.
On the 12th, Celltrion, regarding the recent ruling by the Munich District Court in Germany, said, "It appears the outcome was adversely affected by a precedent in which another bio corporations lost a similar Eylea biosimilar formulation patent case in the same court."
Celltrion emphasized that the scope of the latest ruling is limited to Germany. In a previous case involving another company, a cross-border injunction covering multiple European countries, including Germany, was issued to broadly ban product sales, but in the case of Eydenzelt, the effect was limited to Germany.
By contrast, Belgium reached the opposite conclusion the same day. The Brussels court in Belgium ruled in a preliminary injunction decision that Eydenzelt did not infringe the original formulation patent (set to expire in June 2027). The finding was largely based on the product's formulation differences, including the use of a histidine buffer instead of the phosphate buffer used in the original.
After receiving marketing authorization for Eydenzelt from the European Commission (EC) in February last year, Celltrion has been entering the European market in stages, aligned with each country's patent litigation status. The product has already launched in the United Kingdom, and based on the Belgian court's Jan. 8 (local time) decision, the company is preparing to launch in Belgium as well.
In the U.S. market, the company resolved patent risks in advance. After obtaining approval for Eydenzelt last October, Celltrion reached a patent settlement with Regeneron, the original developer, and is preparing for a U.S. launch at the end of this year. In Canada as well, Celltrion completed a patent settlement with Regeneron in 2024, laying the groundwork to target the North American market.
Celltrion plans to drive a rapid market rollout and sales growth for Eydenzelt, leveraging its direct sales network across the United States and Europe. A Celltrion official said, "We will expand entry into the global market by combining strategic responses tailored to each country's patent environment with patent settlements."